KAS Achieves Landmark $292.5 Million Victory in Guardant Health Case
In a monumental legal victory for the biotechnology field, the Keller Anderle Scolnick (KAS) team has secured a remarkable $292.5 million verdict in the case of Guardant Health Inc. vs. Natera Inc., marking one of the largest outcomes based on the Lanham Act regarding false advertising in legal history. The United States District Court for the Northern District of California ruled largely in favor of Guardant Health, awarding significant sums that include $75 million for corrective advertising, $42 million in disgorgement of profits, and a staggering $175.5 million in punitive damages.
The trial witnessed KAS attorneys, including co-leads Jennifer Keller and Chase Scolnick, and support from Craig Harbaugh and Greg Sergi among others, vigorously advocating for their client, Guardant Health. They faced a formidable defense from Natera's legal team at Quinn Emanuel Urquhart & Sullivan, setting the stage for an intense courtroom battle. Jennifer Keller articulated the necessity for this lawsuit, stressing that it was critical to clarify Guardant's position within the competitive landscape.
Guardant Health’s Reveal™ assay represents a breakthrough in colorectal cancer (CRC) management, utilizing a non-invasive blood test to detect post-surgical cancer recurrence via circulating tumor DNA (ctDNA). This innovative approach dramatically simplifies the testing process for patients unable to provide tumor samples, which can be particularly beneficial for the estimated one-third of CRC patients lacking sufficient tumor tissue for traditional testing methods.
In stark contrast, the rival Natera’s assay, Signatera, relies on tissue samples, potentially complicating the diagnostic process. Keller emphasized the pivotal role of Reveal™ in saving lives while critiquing Natera's aggressive marketing strategies, which included spreading misleading information about Guardant’s product. Their campaign was noted for its early and extensive dissemination of inaccuracies intended to undermine the credibility of the Reveal™ assay.
The aggressive tactics employed by Natera included a concerted effort to suppress accurate studies on the efficacy of Reveal™, aiming to prevent it from gaining the necessary Medicare approval, and launching ad campaigns that misrepresented Guardant Health's innovation.
“In essence, we seek to rectify the record that Natera has skewed through their unconscionable actions,” Keller stated post-verdict. “Our objective is clear: to educate both medical professionals and patients about the unparalleled benefits of Guardant’s Reveal™ assay.” Keller expressed satisfaction at the verdict, highlighting it not only vindicated Guardant Health but also enabled the company to recommence its initiatives for informing the oncology sector about the breakthroughs offered by Reveal™.
With their product commercially launched in February 2021, the culmination of this trial is expected to provide Guardant Health renewed momentum to amplify their messaging concerning the advantages of their innovative blood-based assay. This case serves as a significant marker for the biotechnology sector, underscoring the importance of ethical marketing practices and truthful representation in healthcare innovations as the industry continues to evolve.
The sweeping victory by KAS for Guardant Health stands as a testament to the resolve of the legal team and the necessity for clarity in the face of unfounded competition. As the company moves forward, the implications of this ruling may resonate throughout the biotechnology landscape, establishing new benchmarks for legal disputes surrounding advertising integrity and product claims.
The trial witnessed KAS attorneys, including co-leads Jennifer Keller and Chase Scolnick, and support from Craig Harbaugh and Greg Sergi among others, vigorously advocating for their client, Guardant Health. They faced a formidable defense from Natera's legal team at Quinn Emanuel Urquhart & Sullivan, setting the stage for an intense courtroom battle. Jennifer Keller articulated the necessity for this lawsuit, stressing that it was critical to clarify Guardant's position within the competitive landscape.
Guardant Health’s Reveal™ assay represents a breakthrough in colorectal cancer (CRC) management, utilizing a non-invasive blood test to detect post-surgical cancer recurrence via circulating tumor DNA (ctDNA). This innovative approach dramatically simplifies the testing process for patients unable to provide tumor samples, which can be particularly beneficial for the estimated one-third of CRC patients lacking sufficient tumor tissue for traditional testing methods.
In stark contrast, the rival Natera’s assay, Signatera, relies on tissue samples, potentially complicating the diagnostic process. Keller emphasized the pivotal role of Reveal™ in saving lives while critiquing Natera's aggressive marketing strategies, which included spreading misleading information about Guardant’s product. Their campaign was noted for its early and extensive dissemination of inaccuracies intended to undermine the credibility of the Reveal™ assay.
The aggressive tactics employed by Natera included a concerted effort to suppress accurate studies on the efficacy of Reveal™, aiming to prevent it from gaining the necessary Medicare approval, and launching ad campaigns that misrepresented Guardant Health's innovation.
“In essence, we seek to rectify the record that Natera has skewed through their unconscionable actions,” Keller stated post-verdict. “Our objective is clear: to educate both medical professionals and patients about the unparalleled benefits of Guardant’s Reveal™ assay.” Keller expressed satisfaction at the verdict, highlighting it not only vindicated Guardant Health but also enabled the company to recommence its initiatives for informing the oncology sector about the breakthroughs offered by Reveal™.
With their product commercially launched in February 2021, the culmination of this trial is expected to provide Guardant Health renewed momentum to amplify their messaging concerning the advantages of their innovative blood-based assay. This case serves as a significant marker for the biotechnology sector, underscoring the importance of ethical marketing practices and truthful representation in healthcare innovations as the industry continues to evolve.
The sweeping victory by KAS for Guardant Health stands as a testament to the resolve of the legal team and the necessity for clarity in the face of unfounded competition. As the company moves forward, the implications of this ruling may resonate throughout the biotechnology landscape, establishing new benchmarks for legal disputes surrounding advertising integrity and product claims.
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